Drug Development & Regulation

Marketing Authorization

TRRuhsat
Also known as:Marketing authorisation · Product license · Drug approval

The license granted by a competent regulatory authority that allows a medicinal product to be placed on the market, based on assessment of its quality, safety and efficacy for defined indications and conditions of use.

In depth

Applications are submitted in the ICH Common Technical Document (CTD) format, whose modules cover administrative information, summaries, quality (chemistry, manufacturing and controls), nonclinical and clinical data. Full applications for new active substances contain complete data, whereas generic and biosimilar applications rely partly on the reference product's dossier.

The authorization fixes the approved SmPC, patient leaflet and labeling, and later changes require variations. In Turkey marketing authorization ('ruhsat') is granted by TİTCK; in the EU it is granted centrally (by the European Commission on the recommendation of the EMA) or through national procedures, and in the USA by the FDA.

Clinical pearl

The marketing authorization defines the licensed indications, doses and populations; prescribing outside these terms is off-label use and places greater responsibility on the prescriber.

TRIn Turkish

Ruhsat

Bir tıbbi ürünün piyasaya sunulabilmesi için yetkili düzenleyici otorite tarafından, ürünün belirli endikasyon ve kullanım koşullarındaki kalitesi, güvenliliği ve etkinliği değerlendirilerek verilen izindir.

Başvurular ICH Ortak Teknik Doküman (CTD) formatında sunulur; modülleri idari bilgileri, özetleri, kaliteyi (kimya, üretim ve kontroller), klinik dışı ve klinik verileri kapsar. Yeni etkin maddeler için yapılan tam başvurular eksiksiz veri içerirken jenerik ve biyobenzer başvuruları kısmen referans ürünün dosyasına dayanır.

Ruhsat; onaylı KÜB'ü, kullanma talimatını ve ambalaj bilgilerini de belirler, sonraki değişiklikler varyasyon başvurusu gerektirir. Türkiye'de ruhsat TİTCK tarafından verilir; AB'de merkezi olarak (EMA'nın önerisi üzerine Avrupa Komisyonu tarafından) ya da ulusal prosedürlerle, ABD'de ise FDA tarafından verilir.

Ruhsat, onaylı endikasyonları, dozları ve hasta gruplarını tanımlar; bu koşulların dışında reçeteleme endikasyon dışı kullanımdır ve reçete yazan hekime daha fazla sorumluluk yükler.

Diğer adları:Pazarlama izni · İlaç ruhsatı
Updated 24.09.2026 0 views Educational reference — verify against current sources before clinical use.

Read next

Summary of Product CharacteristicsKısa Ürün Bilgisi

The regulator-approved document that sets out the properties and authorized conditions of use of a medicinal product for healthcare professionals, forming the legal basis of its prescribing information.

 Patient Information LeafletKullanma Talimatı

The leaflet enclosed in a medicine's package that gives patients approved, plain-language information on what the medicine is used for and how to use it safely.

 Phase III Clinical TrialFaz III Klinik Araştırma

A large, usually randomized and controlled confirmatory study in patients that establishes the efficacy and safety of a drug at the intended dose and provides the pivotal evidence for marketing authorization.

 Generic DrugJenerik İlaç

A medicinal product with the same qualitative and quantitative composition in active substance(s) and the same pharmaceutical form as a reference product, whose bioequivalence with that product has been demonstrated.

 Orphan DrugYetim İlaç

A medicine intended for the diagnosis, prevention or treatment of a rare, life-threatening or chronically debilitating condition, which may receive special regulatory designation and development incentives.

 Off-Label UseEndikasyon Dışı Kullanım

The use of an authorised medicine outside the terms of its marketing authorisation, for example for an indication, age group, dose, route or duration not covered by the SmPC.